Dosing control coupling for enteral fluid transfer and enteral couplings and syringes

ABSTRACT

An enteral dosing control coupling comprising a cylindrical collar defining a hollow internal chamber and a lumen extension tip projecting axially into the internal chamber, the lumen extension tip defining an internal lumen extending therethrough. In example forms, the lumen extension tip is integrally formed with the cylindrical collar. In other example forms, the lumen extension tip is a separate piece and is removably engageable within the cylindrical collar. In some example forms, the present invention relates to syringes, connectors, couplings, etc. having ISO 80369-3 formatted couplings. In other example forms, the present invention relates to connectors, couplings, etc. for adapting coupling formats other than the ISO 80369-3 coupling format to the ISO 80369-3 coupling format.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation U.S. Non-Provisional patentapplication Ser. No. 15/659,323 filed Jul. 25, 2017, which claims thepriority benefit of U.S. Provisional Patent Application Ser. No.62/376,006 filed Aug. 17, 2016 and U.S. Provisional Patent ApplicationSer. No. 62/366,399 filed Jul. 25, 2016, and is a continuation-in-partof U.S. Non-Provisional patent application Ser. No. 15/210,282 filedJul. 14, 2016, which claims the priority benefit of U.S. ProvisionalPatent Application Ser. No. 62/192,454 filed Jul. 14, 2015, U.S.Provisional Patent Application Ser. No. 62/207,120 filed Aug. 19, 2015and U.S. Provisional Patent Application Ser. No. 62/350,934 filed Jun.16, 2016, all of which are hereby incorporated herein by reference intheir entireties.

TECHNICAL FIELD

The present invention relates generally to the field of enteral feedingand fluid transfer devices.

BACKGROUND

Healthcare patients and neonates are commonly administered fluids suchas medication and nutrients through the use of enteral fluid deliverysyringes and other enteral fluid transfer and delivery devices.Particularly in smaller volume quantities of enteral fluid delivery,accurate dosing measurement is often highly desirable. Commonly,variations in the size, configuration and positioning of cooperatingcoupling elements of enteral fluid delivery devices can result in dosinginaccuracies.

In particular, enteral syringes and other components having enteral-onlycouplings conforming to the ISO 80369-3 design standard (commonly knownas ENFit®) may have larger dimensions and thus larger contained volumeor displacement within the coupling than previous enteral syringedesigns. Volumetric differences in fluid delivery resulting from thesechanges may adversely affect accuracy of dosing in oral and/or enteraladministration of fluids.

Furthermore, enteral syringes and other components having couplingsformatted differently than the ISO 80369-3 design standard are notconnectable with ISO 80369-3 formatted syringes and components.

Thus it can be seen that needs exist for improved couplingconfigurations for enteral syringes and other components that enablemore accurate control of fluid delivery dosing and connectabilitybetween enteral couplings formatted differently than the ISO 80369-3standard and enteral coupling formatted according to the ISO 80369-3standard. It is to the provision of an improved enteral and/or oraldosing control coupling and enteral syringes and other equipmentincorporating such dosing control couplings that the present inventionis primarily directed.

SUMMARY

In example embodiments, the present invention provides an enteral dosingcontrol coupling and enteral syringes and other equipment incorporatingsuch dosing control couplings that enables more accurate control offluid delivery dosing.

In example forms, the enteral dosing control coupling incorporates amodified female ISO 80369-3 formatted coupling having a lumen extensiontip for engagement within the lumen of a male ISO 80369-3 formattedcoupling. The lumen extension tip reduces the volume of residual fluidcontained in the coupling, and retains a substantially consistent volumeof residual fluid contained in the coupling during fluid transfer intoand out of the enteral syringe. For example, a substantially consistentresidual volume is contained in the lumen extension tip when a syringeincorporating such a dosing control coupling is coupled to a largervolume container for filling, and when the syringe is coupled to afeeding tube for fluid delivery. Furthermore, the syringe incorporatingthe dosing control coupling can be coupled to other ENFit ISO 80369-3formatted couplings and connectors.

In one aspect, the present invention relates to an enteral dosingcontrol coupling including a cylindrical collar defining a hollowinternal chamber and a lumen extension tip projecting axially into theinternal chamber. An internal lumen extends axially through the lumenextension tip. In example embodiments, external coupling members areformed on a portion of the cylindrical collar.

In another aspect, the present invention relates to an enteral syringeincluding a hollow cylindrical barrel and a dosing control coupling. Thehollow cylindrical barrel includes a cylindrical collar with an internalchamber and external coupling members. The dosing control couplingincludes a lumen extension tip projecting axially into the internalchamber, and defining an internal lumen extending therethrough. Inexample embodiments, the cylindrical collar is generally shaped andsized according to the ISO 80369-3 standard. In one example form, thelumen extension tip is generally integrally formed with the cylindricalcollar. In another example form, the lumen extension tip is a separatepiece and configured to provide for removable coupling engagement with aportion of the enteral syringe.

In example forms, the lumen extension tip includes a generally elongatecylindrical body having a base portion for coupling engagement withinthe hollow cylindrical barrel of the enteral syringe. The base portionincludes an outer peripheral surface for engagement with a surfacedefined by the hollow cylindrical barrel. In some example forms, thelumen extension tip comprises a sealing member for providing a sealbetween the hollow cylindrical barrel and the base portion of the lumenextension tip. In example forms, the outer peripheral surface of thebase portion includes one or more engagement features for cooperatingengagement with an engagement feature provided within the hollowcylindrical barrel.

In some example forms, a plunger is axially movable within the barrel tofill and dispense fluid into and from the syringe. The plungeroptionally includes an elongate body having a forward end with aspear-like tip that is insertable within the internal lumen of the lumenextension tip of the syringe such that a contained volume within theinternal lumen of the lumen extension tip is substantially zero. In thisway, dosing inconsistencies and anomalies in accuracy during fluiddelivery are substantially, if not entirely, eliminated.

In yet another aspect, the present invention relates to a lumenextension tip for use with an enteral syringe and for compatible fittingengagement within an internal conduit of a hub of a male ISO 80369-3formatted coupling. The lumen extension tip includes an elongatecylindrical body, an internal conduit extending entirely through thecylindrical body, and a base portion including an outer peripheralsurface and an abutment surface. The outer peripheral surface isconfigured for engagement with a hollow cylindrical barrel of theenteral syringe and the abutment surface is configured for seatingengagement with an upper surface of a platform defined within the hollowcylindrical barrel. In example forms, a sealing member is provided andpositioned between the abutment surface and the upper surface of theplatform. In example embodiments, the outer peripheral surface of thebase portion and an inner surface of the hollow cylindrical barrel canbe shaped and sized to provide for removable engagement therebetween

In yet another aspect, the present invention relates to an enteralsyringe including a hollow cylindrical barrel and a dosing controlcoupling. The hollow cylindrical barrel is adapted to receive a plungerfor retraction and advancement within the syringe barrel to transfer adelivered fluid to and from a contained volume of the syringe barrel.The dosing control coupling extends along an elongate axis from a firstend to a second end. The first end includes a cylindrical outer collardefining a hollow internal chamber and a lumen extension tip projectingaxially into the internal chamber of the collar. The second end includesan end coupling for engagement with the hollow syringe barrel.

In another aspect, the present invention relates to an enteral couplerincluding a coupling member having an elongate body extending a lengthalong a longitudinal axis from a first end to a second end and defininga lumen extending therethrough. The first end includes a femaleformatted coupling and the second end includes a female formattedcoupling. In example embodiments, at least one of the female formattedcouplings includes a female ISO 80369-3 formatted coupling.

In another aspect, the present invention relates to an enteral connectorfor coupling engagement with a syringe including a male ISO 80369-3formatted coupling. The connector includes a female ISO 80369-3formatted coupling including a cylindrical outer collar defining ahollow internal chamber and a lumen extending entirely through the outercylindrical collar.

These and other aspects, features and advantages of example embodimentsof the invention will be understood with reference to the drawingfigures and detailed description herein, and will be realized by meansof the various elements and combinations particularly pointed out in theappended claims. It is to be understood that both the foregoing generaldescription and the following brief description of the drawings anddetailed description are exemplary and explanatory of embodiments of theinvention, and are not restrictive of the invention, as claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an enteral syringe barrel including anenteral dosing control coupling according to an example embodiment ofthe present invention, shown connected to a male ISO 80369-3 formattedcoupling.

FIG. 2 is a second perspective view of the enteral syringe of FIG. 1,disconnected from the male ISO 80369-3 formatted coupling, and showingthe proximal end incorporating a lumen extension tip.

FIGS. 3A-B show cross-sectional views of an enteral dosing controlcoupling according to the present invention, connected to a male ISO80369-3 formatted coupling, showing the small variation of residualvolume contained in the lumen extension tip.

FIG. 4 shows a cross-sectional view of the male ISO 80369-3 formattedcoupling of FIGS. 3A-B.

FIG. 5 shows a cross-sectional view of the female ISO 80369-3 formattedcoupling portion of the enteral syringe of FIGS. 3A-B.

FIG. 6 shows the enteral syringe of FIG. 1, with a tip cap closuremounted on its proximal end.

FIG. 7 shows a cross-sectional view of the enteral syringe and mountedtip cap enclosure of FIG. 6 taken along line 7-7.

FIG. 8 is a perspective view of an enteral syringe including a hollowcylindrical barrel, an enteral dosing control coupling, and a plungermovably mounted within the barrel, according to another exampleembodiment of the present invention.

FIG. 9 is a perspective view of the plunger of FIG. 8, removed from thesyringe barrel.

FIG. 10 is a cross sectional view of the enteral syringe of FIG. 8.

FIG. 11 is a detailed cross-sectional view of the enteral dosing controlcoupling portion of the syringe of FIG. 10.

FIG. 12 shows an enteral syringe including an enteral dosing controlcoupling in the form of a lumen extension tip according to anotherexample embodiment of the present invention, and showing a section ofthe coupling removed to show internal portions thereof.

FIG. 13 shows a detailed view of the enteral syringe of FIG. 12, andshowing the lumen extension tip of the enteral dosing control couplingin a seated and fully extended position.

FIG. 14 shows a detailed view of the enteral dosing control coupling ofFIG. 12, and showing the lumen extension tip of the enteral dosingcontrol coupling at least partially retracted within the syringe.

FIG. 15 shows a detailed view of the enteral dosing control coupling ofFIG. 12, and showing the lumen extension tip of the enteral dosingcontrol coupling entirely removed from the syringe.

FIG. 16 shows a cross-sectional view of the enteral syringe of FIG. 12.

FIG. 17 shows the lumen extension tip of FIG. 12 retracted within thesyringe by misconnecting a non-ENFit enteral connector with the lumenextension tip.

FIG. 18 shows a cross-sectional view of an enteral syringe with thelumen extension tip thereof having a sealing member according to anotherexample embodiment of the present invention.

FIG. 19 shows a cross-sectional view of an enteral syringe with thelumen extension tip thereof having a sealing member and interengagementfeatures according to another example embodiment of the presentinvention.

FIG. 20 shows a cross-sectional view of an enteral syringe with thelumen extension tip thereof having a sealing member and interengagementfeatures according to another example embodiment of the presentinvention.

FIG. 21 shows a cross-sectional view of an enteral syringe with thelumen extension tip thereof having interengagement features according toanother example embodiment of the present invention.

FIG. 22 is a perspective cross-sectional view of a portion of a syringeincluding an enteral dosing control coupling having a lumen extensiontip seated and fully extending from the end of the syringe according toanother example embodiment of the present invention.

FIG. 23 is a cross-sectional view of the lumen extension tip portion ofthe syringe of FIG. 22.

FIG. 24 is a perspective view of a syringe having a dosing controlcoupling according to another example embodiment of the presentinvention.

FIG. 25 shows a cross-sectional view of the syringe of FIG. 24 takenalong line 25-25.

FIG. 26 is a perspective view of a syringe having a dosing controlcoupling according to another example embodiment of the presentinvention.

FIG. 27 shows a cross-sectional view of the syringe of FIG. 24 takenalong line 27-27.

FIGS. 28A-B show cross-sectional view of an enteral syringe including anenteral dosing control coupling according to another example embodiment,showing an assembly view with components thereof disconnected and anassembled view with the components connected together.

FIGS. 29A-C show perspective and front views of an enteral syringeincluding a dosing control coupling according to another exampleembodiment of the present invention.

FIG. 30 shows a cross-sectional view of a syringe including a dosingcontrol coupling according to another example embodiment of the presentinvention.

FIG. 31 shows a cross-sectional view of an enteral syringe including adosing control coupling according to another example embodiment of thepresent invention.

FIG. 32 shows a cross-sectional view of an enteral syringe including anenteral dosing control coupling according to another example embodimentof the present invention.

FIG. 33 shows cross-sectional view of an enteral syringe according toanother example embodiment of the present invention.

FIG. 34 shows the cross-sectional view of the enteral syringe of FIG.33, and showing a tab extending from a portion of the syringe body.

FIG. 35 shows cross-sectional view of an enteral syringe according toanother example embodiment of the present invention.

FIG. 36 shows the cross-sectional view of the enteral syringe of FIG.35, and showing a tab extending from a portion of the syringe body.

FIGS. 37A-D show cross-sectional views of enteral couplers according toexample embodiments of the present invention.

FIGS. 38A-D show cross-sectional views of enteral couplers according toexample embodiments of the present invention.

FIGS. 39A-D show cross-sectional views of enteral couplers according toexample embodiments of the present invention.

FIGS. 40A-D show cross-sectional views of enteral couplers according toexample embodiments of the present invention.

FIGS. 41A-D show cross-sectional views of enteral couplers according toexample embodiments of the present invention.

FIG. 42A shows a perspective view of an enteral coupler according toanother example embodiment of the present invention.

FIG. 42B shows a cross-sectional view of the enteral coupler of FIG.42A.

FIG. 42C shows the cross-sectional view of the enteral coupler of FIG.42B, and further including an enteral dosing control coupling.

FIG. 43A shows a perspective view of an enteral coupler according toanother example embodiment of the present invention.

FIG. 43B shows a cross-sectional view of the enteral coupler of FIG.43A.

FIG. 43C shows the cross-sectional view of the enteral coupler of FIG.43B, and further including an enteral dosing control coupling.

FIG. 44A shows a perspective view of an enteral coupler according toanother example embodiment of the present invention.

FIG. 44B shows a cross-sectional view of the enteral coupler of FIG.44A.

FIG. 44C shows the cross-sectional view of the enteral coupler of FIG.44B, and further including an enteral dosing control coupling.

FIG. 45A shows a perspective view of an enteral coupler according toanother example embodiment of the present invention.

FIG. 45B shows a cross-sectional view of the enteral coupler of FIG.45A.

FIG. 45C shows the cross-sectional view of the enteral coupler of FIG.45B, and further including an enteral dosing control coupling.

FIG. 45D shows a perspective view of the enteral coupler of FIG. 45A,and showing a hole formed in a tab member thereof.

FIGS. 46A-C show cross-sectional view of a fluid transfer lid accordingto example embodiments of the present invention.

FIGS. 47A-B show a detailed cross-sectional view of the fluid transferlid of FIG. 46B, and further including a dosing control coupling.

FIG. 48 shows a cross-sectional view of the enteral syringe of FIG. 34coupled with a tip cap according to another example embodiment of thepresent invention.

FIG. 49 shows the cross-sectional view of the tip cap of FIG. 48.

FIGS. 50-51 show cross-sectional views of a tip cap according to exampleembodiments of the present invention.

FIGS. 52-54 show cross-sectional views of a tip cap according to exampleembodiments of the present invention.

FIG. 55 shows a cross-sectional view of a tip cap according to anotherexample embodiment of the present invention.

FIGS. 56A-C show perspective view of oral administration couplersaccording to example embodiments of the present invention.

FIGS. 57A-C show cross-sectional views of the oral administrationcouplers of FIGS. 56A-C.

FIGS. 58A-C show perspective views of an oral administration couplersaccording to example embodiments of the present invention.

FIGS. 59A-C show cross-sectional views of the oral administrationcouplers of FIGS. 58A-C.

DETAILED DESCRIPTION OF EXAMPLE EMBODIMENTS

The present invention may be understood more readily by reference to thefollowing detailed description taken in connection with the accompanyingdrawing figures, which form a part of this disclosure. It is to beunderstood that this invention is not limited to the specific devices,methods, conditions or parameters described and/or shown herein, andthat the terminology used herein is for the purpose of describingparticular embodiments by way of example only and is not intended to belimiting of the claimed invention. Any and all patents and otherpublications identified in this specification are incorporated byreference as though fully set forth herein.

Also, as used in the specification including the appended claims, thesingular forms “a,” “an,” and “the” include the plural, and reference toa particular numerical value includes at least that particular value,unless the context clearly dictates otherwise. Ranges may be expressedherein as from “about” or “approximately” one particular value and/or to“about” or “approximately” another particular value. When such a rangeis expressed, another embodiment includes from the one particular valueand/or to the other particular value. Similarly, when values areexpressed as approximations, by use of the antecedent “about,” it willbe understood that the particular value forms another embodiment.

With reference now to the drawing figures, wherein like referencenumbers represent corresponding parts throughout the several views,FIGS. 1-7 show an enteral syringe 10 comprising an enteral dosingcontrol coupling or low-dose tip according to an example embodiment ofthe invention. In example embodiments, the enteral syringe 10 includes ahollow cylindrical barrel 20, a base flange 30 at a distal end of thebarrel, and an enteral dosing control coupling 40 at a proximal end ofthe barrel. As would be understood by one of ordinary skill in the art,the barrel 20 is adapted to receive a syringe plunger (see FIG. 8, aswill be described below), which is axially advanced and retracted withinthe barrel to fill and dispense fluid into and from the syringe intypical fashion. A positioning flange 22 optionally extends transverselyoutward from the barrel 20, proximal the coupling 40. In some exampleembodiments, the syringe can be provided for use with a syringe pump,for example, where one or more portions of the syringe and/or theplunger can be interengageable with one or more portions of the syringepump for moving the plunger relative to the syringe to dispense fluidsfrom the syringe.

In the depicted example embodiment, the coupling 40 generally comprisesa modified female ISO 80369-3 formatted coupling substantiallyconforming to ISO design standard 80369-3, and is engageable with acompatible coupling element such as a corresponding male ISO 80369-3formatted coupling M, as shown in FIG. 1. In example applications, themale ISO 80369-3 formatted coupling M can be part of a feeding orextension tube, a pharmacy cap, or other enteral fluid deliveryequipment to which the syringe 10 is to be coupled. As used herein, itis to be understood that the terms “ISO 80369-3 formatted” or “ISO80369-3 format” are intended to be broadly construed to include ISO80369-3 compatible, ISO 80369-3 compliant, or both ISO 80369-3compatible and ISO 80369-3 compliant according to the ISO 80369-3 designstandard.

As depicted in FIGS. 2 and 5, the coupling 40 comprises a cylindricalouter collar 42 defining a hollow internal chamber, and a pair ofhelical coupling lugs 44 projecting outwardly from the exterior surfaceof the collar. Optionally, rather than lugs 44 projecting from theexterior surface of the collar, the exterior surface of the collar 42can comprise helical threads generally extending about at least aportion of the exterior surface thereof, for example, like threads on abolt, other types of conventional coupling members, etc. In some exampleembodiments, the exterior surface of the collar is entirely smoothwithout any lugs, for example, whereby a frictional fit (as will bedescribed below) will be provided between the male ISO 80369-3 formattedcoupling M and the coupling 40.

The coupling 40 further comprises a lumen extension tip 46, projectingaxially from the barrel 20 of the syringe into the internal chamber ofthe collar 42. An internal lumen or enteral fluid delivery conduit 48extends through the lumen extension tip 46 for fluid communication toand from the contained volume of the barrel 20, allowing fluid deliveryin and out of the barrel. As shown in cross-section by FIGS. 3A-B, whenthe coupling 40 is engaged with a male ISO 80369-3 formatted coupling M,the lumen extension tip 46 is received within the lumen of a malecoupling hub H (in effect becoming a male coupling element within the“female” lumen of the male ISO 80369-3 formatted coupling). The lumenextension tip 46 is generally cylindrical or tubular and includes aninternal surface defining the lumen or fluid delivery conduit 48, acylindrical or slightly tapered external surface, and a distal tip atits free end. The outer coupling collar 42 is also generally cylindricalor tubular, and at least partially surrounding the lumen extension tip46. The collar 42 comprises an internal surface confronting and spaced adistance apart from the external surface of the lumen extension tip, andfurther comprises an external surface optionally comprising the lugs 44or other coupling or connection features, and an outer rim at its distalfree end. The internal dimension of the collar 42 is greater than theexternal dimension of the lumen extension tip 46, such that a spacetherebetween forms a receiver for a cooperating portion of a compatiblecoupling element. The lumen extension tip 46 is positioned generallyconcentrically and coaxially within the collar 42, and the lumen 48extends generally centrally through the lumen extension tip alsoconcentric and coaxial with the collar.

According to example embodiments, the lumen extension tip 46 isintegrally formed with the coupling 40 whereby an internal end surfaceof the barrel 20 provides support for the extension of the tip 46 withinthe internal chamber of the collar 42. Typically, the lumen extensiontip 46 is generally sized and shaped for substantially fitting withinthe lumen of the male coupling hub H of the male ISO 80369-3 formattedcoupling M (see FIGS. 3A-B). In example embodiments, the coupling 40(comprising the lumen extension tip 46) is preferably engagable with ISO80369-3 formatted connectors (e.g., compliant or compatible). In someexample embodiments, the extension of the tip 46 does not extend beyondan end of the collar 42, for example, such that the tip is recessedbetween about 0.45-0.65 millimeters below the end of the collar 42, forexample about 0.55 millimeters according to example embodiments.However, according to other example embodiments, the tip 46 extendsbeyond the end of the collar 42. In example embodiments, the size, shapeand extension of the tip 46 is generally configured for compatibleengagement within the lumen of the male coupling hub H.

In example embodiments, the lumen extension tip 46 is configured suchthat dosing inconsistencies and anomalies in accuracy during fluiddelivery are reduced, minimized or substantially eliminated. Withrespect to the coupling configuration shown in FIGS. 3A-B, it can beseen that the lumen extension tip 46 retains a substantially consistentvolume of residual fluid contained in the internal lumen 48 of theextension tip during fluid transfer into and out of the enteral syringe.In example embodiments, the contained volume CV of the lumen extensiontip 46 is between about 0.005 milliliters to about 0.03 milliliters, andmore preferably about 0.01 milliliters (see FIG. 3B). In exampleembodiments the combined tip volume CTV (e.g., lumen plus the rest ofthe fluid space in the tip) is preferably about 0.017 milliliters (seeFIG. 3A).

As depicted in FIG. 4 and as described above, the male coupling M ispreferably formatted according to the ISO 80369-3 standard. For example,the male coupling hub H comprises a first outer diameter D1 that isdefined at an end of the hub H adjacent the beginning of a tapered endsurface (defined by angle α), a second outer diameter D2 that is definedat a length L1 from the end of the hub H adjacent the taper. Theinternal lumen of the hub H is defined by a diameter D3. An outer collarOC generally surrounds the hub H for providing coupling engagement withthe lugs 44 of the coupling 40 of the syringe 10. The outer collarcomprises a minor inside thread diameter D4 and a major inside threaddiameter D5. The length of the hub H from the end of the outer collar OCis defined by a length L2. In typical configurations, the first outerdiameter D1 is about 5.41 millimeters, the second outer diameter D2 isabout 5.64 millimeters, the internal lumen diameter D3 is about 2.90millimeters, the minor inside thread diameter D4 is about 8.65millimeters, the major inside thread diameter D5 is about 10.23millimeters, and the angle α is about 45 degrees. In someconfigurations, the diameter D5 is larger than 10.23 millimeters, forexample, wherein the male hub H generally relies on frictionalengagement with the coupling 40 (e.g., instead of the lugs 44 engagingthe threads of the outer collar OC). Alternatively, the collar 42 can besubstantially smooth without lugs such that the outer collar 42 cangenerally pass between the first and second diameters D1, D2 of the hubH and the minor inside thread diameter D4, for example, where africtional fit is provided between the hub H and an interior or innerwall of the collar 42. The length L1 is about 3.82 millimeters and thelength L2 is about 6.82 millimeters or greater.

In example embodiments, the coupling 40 (and enteral dosing controlcoupling thereof) is formatted according to the ISO 80369-3 standard,for example, to provide for coupling engagement with the male coupling M(and the hub H thereof). For example, as depicted in FIG. 5, thecoupling 40 comprises a first internal diameter D6 and a second internaldiameter D7 that are spaced a length L3 between each other. The lumenextension tip 46 comprises a first outer diameter D8 defined near itsend and a second outer diameter D9 defined at the connected side of thetip 46. An angled taper (defined by an angle β) is provided between thebase end of the tip 46 and an internal surface of the collar 42. Thelugs 44 of the collar 42 define a minor outside thread diameter D10 anda major outside thread diameter D11. According to example embodiments,the first internal diameter D6 is about 5.69 millimeters, the secondinternal diameter D7 is about 5.26 millimeters, the first outer diameterD8 of the tip 46 is about 2.50 millimeters, the second outer diameter D9of the tip 46 is about 2.85 millimeters, the minor outside threaddiameter D10 is about 8.10 millimeters, and the major outside threaddiameter D11 is about 9.93 millimeters. The length L3 defined betweenthe first and second internal diameters D6, D7 is about 7.14millimeters, and the angle β of the angled taper is about 45 degrees.Optionally, according to alternate example embodiments, the malecoupling M and the coupling 40 can be sized as desired.

In example embodiments, the first and second outer diameters D8, D9 ofthe lumen extension tip 46 are generally sized and shaped to provide forcompatible fitting engagement within the internal lumen of the hub H ofthe male coupling M (defined by internal diameter D3). Thus, with theinternal lumen diameter D3 being about 2.90 millimeters, the first andsecond outer diameters D8, D9 are preferably sized to provide forfitting engagement within the internal lumen thereof. In some exampleembodiments, the first and second diameters D8, D9 are configured suchthat little to no interference is provided between the tip 46 and theinternal lumen of the hub H. Alternatively, the first and seconddiameters D8, D9 can be configured such that at least some interferenceis provided therebetween to frictionally and/or sealingly engage the twotogether.

In example embodiments, the lumen extension tip 46 preferably assists inthe prevention of unwanted fluid transfer when uncoupling the couplinghub H from the syringe 10. Typically, a vacuum is formed when thecoupling hub H and the syringe 10 are coupled together and fluid iscommunicating therebetween (or stagnant therein). Thus, by providing thelumen extension tip 46, a smaller quantity of fluid is present andsubject to being transferred back into the syringe 10. Accordingly,provision of the lumen extension tip 46 preferably minimizes theunwanted transfer of fluid, which is intended to be carried within andout of the coupling hub H, from being drawn back into the syringe 10when the connection between the coupling hub H and the lumen extensiontip 46 is broken.

While the coupling 40 comprising the lumen extension tip 46 is describedand shown herein as part of an enteral syringe, it will be understoodthat the lumen extension tip of the present invention may beincorporated in the coupling elements of various other types of enteralfluid collection, storage and/or transfer devices as well. Thus, thepresent invention includes without limitation, a coupling (such as forexample, a modified female ISO 80369-3 formatted coupling) including alumen extension tip as disclosed, as well as enteral fluid collection,storage and/or transfer devices comprising such a coupling, for example,syringes of differing sizes and formats, enteral fluid collectiondevices, enteral fluid storage devices, enteral fluid delivery ortransfer tubes or conduits, enteral connectors or couplings, and thelike, as well as accessories, couplings and adaptors for use inconnection with various ISO 80369-3 formatted or non-ENFit enteral fluidstorage and delivery devices.

For example, according to one example embodiment as depicted in FIGS.6-7, a tip cap TC can be coupled to the coupling 40 for sealing theinternal lumen 48 to prevent fluids from dispensing from the internallumen, and for preventing debris and contaminants from contacting thecoupling 40 and internal lumen 48. According to one example embodiment,the tip cap TC comprises a male hub H (as described above) for providinginterengagement with the coupling 40 (and for permitting extension ofthe lumen extension tip 46 within the internal cavity of the male hubH). According to one example embodiment, the tip cap TC comprises acoaxial connection collar that is modified to comprise a radial array oftwo or more split retainer tab members or clips COC, which are generallyat least partially flexible and resilient for outwardly flexing duringengagement with the lugs 44 of the coupling 40. U.S. patent applicationSer. No. 15/078,674 (Attorney Docket No. 2N11.1-322), U.S. patentapplication Ser. No. 15/185,583 (Attorney Docket No. 2N11.1-351), U.S.patent application Ser. No. 14/844,922 (Attorney Docket No. 2N11.1-313),U.S. Design Patent Application Ser. No. 29/521,665 (Attorney Docket No.2N11.1-300), and U.S. Design Patent Application Ser. No. 29/533,173(Attorney Docket No. 2N11.1-301) are incorporated herein by referenceand disclose various clipped, snap-on and dual-action attachment andremoval mechanisms. Optionally, one or more of the ends of the couplingscan be provided with tabs or clips for providing permanent engagementbetween the coupling and the compatible connector, for example, when itis intended to prevent removal of the coupling 40 (and syringe 10thereof) from the compatible connector after use.

In an example method of use, a syringe 10 is connected to anotherenteral fluid delivery component by engagement of the modified femaleISO 80369-3 formatted coupling 40 of the syringe with a male ISO 80369-3formatted coupling, in typical fashion. The lumen extension tip of thesyringe coupling is received within the lumen of the male ISO 80369-3formatted coupling. Fluid is transferred in or out of the syringe, fromor to the other enteral fluid delivery component by retracting oradvancing the syringe plunger. A reduced and substantially consistentresidual volume is contained in the lumen extension tip duringsequential fluid transfer operations, thereby maintaining accuratedosing control.

According to an example embodiment of the present invention, the plungerof the syringe is preferably configured such that an end thereof extendswithin the internal lumen 48 of the lumen extension tip 46 as theplunger is advanced into the syringe body for fluid delivery, forexample, to eliminate the dead space within the internal lumen 48 of thelumen extension tip 46 so that dosing inconsistencies and anomalies inaccuracy during fluid delivery are further reduced, minimized orsubstantially eliminated. As shown in FIGS. 8-9, for example, an enteralsyringe 100 is shown and comprises a plunger 150 movably mounted withina hollow cylindrical barrel 120. In example embodiments, the plunger 150comprises a generally elongate body 152 comprising a forward end portion154 having a displacement member or generally spear-like tip or rod 156at a forward end thereof. In the depicted embodiment, the forward end154 includes a forward body portion 160, and a seal ring or gasket 162positioned generally adjacent the forward end portion (see FIG. 9).Optionally, the rearward end of the plunger 150 can comprise anactuating flange or feature 164 for providing manipulation thereof topush or pull the plunger 150 into and out of the hollow cylindricalbarrel 120.

FIGS. 10-11 show a cross-sectional view of the syringe 100 with theplunger 150 fully inserted within the hollow cylindrical barrel 120 andthe tip 156 fully inserted within the internal lumen 148 of the lumenextension tip 146 of the modified ISO 80369-3 formatted coupling 140.Preferably, with the plunger 150 fully inserted therein, the containedvolume within the internal lumen 148 of the lumen extension tip 146 issubstantially zero, and thus, dosing inconsistencies and anomalies inaccuracy during fluid delivery are substantially, if not entirely,eliminated. Typically, the size of the tip 156 is substantially similarto the size and shape of the internal lumen 148, and the size and shapeof the elongate body 152 and forward end body portion 160 aresubstantially similar or slightly smaller than the size and shape of thehollow cylindrical barrel 120. According to example embodiments, thesize of the gasket 162 is generally slightly greater than the size ofthe hollow cylindrical barrel 120.

FIGS. 12-17 show an enteral syringe 200 comprising an enteral dosingcontrol coupling 240 according to another example embodiment of theinvention. As similarly recited above, the enteral syringe 200 includesa hollow cylindrical barrel 220, a base flange 230 at a distal end ofthe barrel, and the enteral dosing control coupling 240 at a proximalend of the barrel. The barrel 220 is adapted to receive a syringeplunger, which is axially advanced and retracted within the barrel tofill and dispense fluid into and from the syringe in typical fashion. Inexample embodiments, a lumen extension tip 246 is generally floating ormovable with respect to the syringe (e.g., a separate piece), and isgenerally fitted and interengageable within the barrel of the syringesuch that at least a portion thereof extends from the coupling 240 (assimilarly described above). According to example embodiments,configuring the lumen extension tip as a separate piece further de-risksthe chances of a misconnection with a non-ENFit connector, and asubstantially wide variety of options are available regarding themanufacturing and assembly of the tip and the syringe.

The lumen extension tip 246 comprises an internal lumen 248, andfunctions substantially similarly to the embodiments as described above,for example, such that dosing control inaccuracies are substantiallyeliminated to provide for accurate dosing control. As depicted in FIGS.12-15, a portion of the coupling 240 is removed to show internalportions thereof. However, according to some example embodiments, thecoupling 240 can comprise one or more cut-outs or removed sections(e.g., as depicted) to facilitate the removal and evacuation of anyfluids that are contained within the coupling 240, for example, withinthe area defined between the lumen extension tip 246 and an interiorwall portion of the coupling 240. In some example embodiments, about onecut-out portion is formed within the coupling 240. In other exampleembodiments, two or more cutouts are formed within the coupling 240.According to some example embodiments, one or more openings can beformed along any portion of the coupling 240, for example, to act as adrain or exit conduit for facilitating the removal of unwanted fluids.

As depicted in FIGS. 13 and 16, the lumen extension tip 246 ispreferably configured for fitting within at least a portion of thebarrel 220, for example, such that at least a portion of the tip 246extends coaxially within at least a portion of coupling 240, or withinat least a portion of the space defined and surrounded by the collar ofthe modified female ISO 80369-3 formatted coupling substantiallyconforming to ISO design standard 80369-3, and is engageable with acorresponding male ISO 80369-3 formatted coupling M, as shown in FIG. 1.As depicted in FIG. 15, the lumen extension tip 246 generally comprisesa cylindrical body defining the conduit 248 extending therethrough. Inexample embodiments, an end of the cylindrical body comprises a baseportion 270 having an outer peripheral surface 272 for being retainedwithin the internal conduit of the barrel. Furthermore, a contact orabutment surface 274 is provided for engaging a portion of the internalconduit within the barrel 220 (e.g., to define an in-use, fully-extendedposition). For example, as shown in FIGS. 15 and 17, an end of theinternal conduit within the barrel 220 comprises an outer shelf orinwardly directed platform 243 defining an upper surface 243 a forcontact with the abutment surface 274 of the lumen extension tip 246,and wherein a centrally-positioned opening or conduit 221 is defined forreceiving the cylindrical body of the lumen extension tip 246. Inexample embodiments, the outer peripheral surface 272 is generallysimilar in diameter and generally parallel with at least a portion ofthe internal conduit of the syringe barrel 220. In example embodiments,a frictional fit is provided between the outer wall of the internalconduit of the barrel 220 and the outer peripheral surface 272 of thebase portion 270, or at least when the abutment surface 274 iscontacting the upper surface 243 a of the platform 243. For example, toensure fluids do not pass around the outer peripheral surface 272 andthrough the conduit 221 of the syringe coupling 240 (e.g., leaking fromthe coupling and not being contained within the internal lumen 248), aninterference fit is generally provided between the at least a portion ofthe base 270 and the platform 243.

In some example embodiments, as depicted in FIG. 18, a seal ring orgasket 280 is generally provided for seating against the abutmentsurface 274 and around the cylindrical body 246, and thereby providingfor an enhanced seal between the upper surface 243 a and the abutmentsurface 274. In example embodiments, when the gasket 280 is provided,the outer diameter of the outer peripheral surface 272 need not be theexact same size or larger for providing an interference fit. However, insome example embodiments, the outer diameter of the outer peripheralsurface 272 is generally substantially similar to the diameter of theinternal conduit of the barrel 220 generally near the platform 243, forexample, to provide an interference fit therebetween. In some exampleembodiments, the diameter of the internal conduit of the barrel 220varies along its length, for example, at least partially varying ortapering along its length such that sufficient retraction of the lumenextension tip 246 within the internal conduit of the barrel 220 (seeFIG. 17) will eventually cause the lumen extension tip 246 to becomefree from engagement with the internal conduit of the barrel 220. Insome example embodiments, the outer peripheral surface 272 generallyremains in contact with the outer surface of the internal conduit of thebarrel 220.

For example, as depicted in FIG. 17, a non-ENFit connector IC is shownattempting to misconnect with the lumen extension tip 246. As the ISO80369-3 standard facilitates a reduction of misconnections betweendifferent enteral connectors, configuring the lumen extension tip 246 tobe a separate piece can further reduce or de-risk the likelihood of amisconnection, for example, whereby attempting to connect the non-ENFitconnector IC to the tip 246 causes the lumen extension tip 246 toretract within the internal conduit of the barrel 220. In exampleembodiments, with the lumen extension tip 246 being movable within theinternal conduit of the barrel 220, in the event of a user incorrectlyattempting to couple non-ENFit connectors with the coupling 240 (andlumen extension tip 246 thereof), such misconnection is substantially(if not entirely) prevented, for example, since direct engagement withthe lumen extension tip 246 causes retraction of the tip 246 relative tothe internal conduit of the barrel 220. And thus, with the lumenextension tip 246 retracted within the internal conduit of the barrel,the syringe is incapable of properly functioning and thereby warning auser of the potential misconnection and/or preventing non-ENFitconnectors from being unintentionally misconnected with the lumenextension tip. In example embodiments, the force required to causeretraction of the lumen extension tip 246 can be adjusted based on theinterference provided between the lumen extension tip 246 (and the base270 thereof) and the internal conduit of the barrel 220 (or with otherportions of the syringe). For example, according to some exampleembodiments, only a relatively small force is required to causeretraction of the lumen extension tip 246. Alternatively, in otherexample embodiments, a larger force is required to cause retraction ofthe lumen extension tip 246 within the internal conduit of the barrel220. Preferably, the interference provided between the lumen extensiontip and the syringe can be adjusted as desired such that the desiredforce causes retraction of the lumen extension tip within the internalconduit of the barrel.

As depicted in FIGS. 19-21, the base 270 of the lumen extension tip 246can preferably be configured in various forms such that coupling and/orsealing engagement is provided between the base 270 (or at least aportion of the lumen extension tip 246) and the internal conduit of thebarrel 220 or platform 243. FIG. 19 shows the lumen extension tip 246seated within the internal cavity and projecting coaxially within thecoupling 240. In example embodiments, the base 270 comprises anoutwardly curved peripheral surface 272 a for engagement with a radiusedrecess formed in the outer surface of the internal conduit of the barrel220. In alternate example embodiments, the interengagement providedbetween the outwardly curved peripheral surface 272 a and the radiusedrecess provides a sufficient seal therebetween (see FIG. 19), andpreferably provides for sufficient seating engagement therebetween. Insome example embodiments, the interference between the outwardly curvedperipheral surface 272 a and the radiused recess is such that anon-ENFit connector attempting to misconnect with the lumen extensiontip 246 causes the base 270 and the outwardly curved peripheral surface272 a of the lumen extension tip 246 to disengage the radiused recessand begin to move rearwardly within the internal lumen of the barrel 220(e.g., similar to the tip 24 of FIG. 17).

Alternatively, as depicted in FIG. 20, the base 270 of the lumenextension tip 246 comprises an inwardly directed outer peripheralsurface 272 b for interengagement with a radiused ring or rib of theouter surface of the internal cavity of the barrel 220. Optionally, aseal ring 280 is provided between the abutment surface 274 and the uppersurface 243 a. According to another example embodiment, a protruding ribor ring 282 extends from the abutment surface 274 for interengagementwithin a circular recess formed within a portion of the platform 243(see FIG. 21). Optionally, according to other example embodiments, thelumen extension tip 246 (e.g., cylindrical body and/or base) can beshaped and sized as desired, and can be configured for removable orpermanent interengagement with the internal lumen of the barrel (orother portions of the syringe). Optionally, as described above, theinterengagement between the lumen extension tip and the syringe is suchthat an attempted misconnection with a non-ENFit connector is de-riskedby retraction of the lumen extension tip within the internal conduit ofthe barrel 220. In example embodiments, with the lumen extension tip 246being separate and movable with respect to the syringe, the likelihoodof non-ENFit connectors being unintentionally misconnected with thelumen extension tip 246 is substantially reduced. As such, the incidenceof potential misconnections with other coupling formats, for example,luer slip couplings or other coupling formats, can be reduced oravoided. For example, in example embodiments, attempting to connectother coupling formats that are not configured according to a couplingsubstantially conforming to ISO 80369-3 design standard will cause thelumen extension tip 246 to move within the syringe, and thus, provide awarning the user and/or will not allow for connecting with the non-ENFitcoupling format.

According to other example embodiments, the lumen extension tip 246 cancomprise one or more engagement features for providing interengagementwith the internal conduit of the barrel 220 (or other portions of thesyringe 200), and the plunger movably mounted within the barrel 220 canpreferably provide for manipulating or facilitating movement of thelumen extension tip 246 within the internal conduit of the barrel 220,for example, to provide for selective engagement/disengagement of thelumen extension tip 246 within the internal conduit of the barrel 220.According to example embodiments, one or more teeth or coupling featuresare provided on a portion of the base 270 for engagement with a portionof the plunger. And, one or more interengagement features are providedwith the lumen extension tip 246 for coupling engagement with theinternal conduit of the barrel 220 (or other portions of the syringe).Thus, according to some example embodiments, the plunger can engage theone or more coupling features of the base 270 such that the lumenextension tip 246 can be manipulated (or rotationally driven) to providefor selective engagement/disengagement of the lumen extension tip 246with the syringe 200.

FIGS. 22-23 show a syringe 300 comprising a lumen extension tip 346according to another example embodiment of the present invention. Inexample embodiments, the syringe 300 is generally similar to the syringe200 as described above. In example embodiments, the first and secondinternal diameters D6, D7 of the collar 340 and the length L3 definedtherebetween are substantially similar as described above. For example,the first internal diameter D6 is about 5.69 millimeters, the secondinternal diameter D7 is about 5.26 millimeters, and the length L3defined between the first and second internal diameters D6, D7 is about7.14 millimeters. In example embodiments, the diameter D12 of thecentral opening of the syringe 300 (e.g., for receiving the lumenextension tip 346) is about 2.80 millimeters, and the diameter D13 ofthe internal conduit of the syringe barrel 320 is about 4.69millimeters.

As depicted in FIG. 23, the lumen extension tip 346 is generallysimilarly shaped as described above and comprises a cylindrical bodyhaving a base 370 at an end thereof and comprising an internal lumen 348extending entirely through the cylindrical body. In example embodiments,the outer diameter D13 of the internal conduit of the barrel 320 issubstantially similar to the outer diameter D13 of the base 370, forexample, which is about 4.69 millimeters. Thus, according to exampleembodiments, the outer diameter D13 of the base 370 is sized to providefor an interference, frictional fit with the internal conduit of thebarrel 320. The base 370 comprises a thickness T1 of about 0.64millimeters and the outer peripheral surface 372 is generallysubstantially flat and generally parallel relative to the axis Xlongitudinally extending along a length L4 of the tip 346. A bottom sideof the base 270 comprises a slightly tapered surface that is generallyangled towards the opening of the internal conduit 348. In exampleembodiments, the length L4 (defined between the ends of the tip 346) isabout 8.76 millimeters. As similarly described above, the base 370 ofthe tip 346 comprises an abutment surface 374 for engagement with theupper surface 343 a of the platform 343. The internal conduit 348 of thetip 346 comprises a first inner diameter D14 defined near the base 370and a second inner diameter D15 the end of the tip. In exampleembodiments, the first inner diameter is about 1.33 millimeters and thesecond inner diameter D15 is about 1.40 millimeters. The outer diameterof the end of the tip 346 defines an outer diameter D16, which is about2.51 millimeters according to one example embodiment. In exampleembodiments, the outer periphery of the cylindrical body of the tip 346comprises a surface 347 that is provided for fitting within the internalcavity of a male hub H of an ISO 80369-3 formatted connector. In exampleembodiments, the end of the tip 346 generally near the outer diameterD16 con comprise a radiused edge or other curved or tapered feature. Asdepicted, a radiused edge is provided at the end portion of the tip 346.

FIGS. 24-27 show syringes 400, 500 comprising lumen extension tips 446,546 according to additional example embodiments of the presentinvention. In example embodiments, the dosing control couplings (asdescribed above) can be adapted for use with syringes of differentsizes. For example, FIGS. 24-25 depicts a 3 milliliter syringe 400comprising a syringe body 420, an ISO 80369-3 formatted enteral dosingcontrol coupling 440 in the form of a modified female ENFit coupling.The lumen extension tip 446 can be integrally formed with the couplingas depicted, or in alternate embodiments can be a separate component.Similarly, FIGS. 26-27 show a 6 milliliter syringe 500 comprising asyringe body 520, an ISO 80369-3 formatted enteral dosing controlcoupling 540 in the form of a modified female ENFit coupling positionedoffset from the barrel of the syringe. The lumen extension tip 446 canbe integrally formed with the coupling. Alternatively, the lumenextension tips 446, 546 can be separate and movable with respect to thesyringe, for example, as described above with respect to FIGS. 12-23. Inexample embodiments, the enteral dosing control couplings 440, 540 ofthe syringes 400, 500 can be applied to syringes of various volumes andshapes, for example, between about 0.5 milliliters-6 milliliters andwherein the dosing control couplings can be positioned concentrically,off-centered, or asymmetrical relative to the syringe body. In stillother embodiments, a low-dose tip or dosing control coupling accordingto any of the embodiments as disclosed herein can be provided inconnection with various other syringe formats including, for examplesyringes having non-circular barrel configurations (see U.S. patentapplication Ser. No. 14/224,297, incorporated herein by reference in itsentirety).

FIGS. 28A-B show an enteral syringe 600 comprising an enteral dosingcontrol coupling or low-dose tip 646 according to an example embodimentof the invention. In example embodiments, the enteral syringe 600includes a hollow cylindrical barrel 620 and an enteral dosing controlcoupling 640 for coupling with a proximal end of the barrel. Accordingto the depicted example embodiment, the hollow cylindrical barrel 620and the dosing control coupling 640 are separate pieces configured forsealingly engaging each other. Optionally, the barrel 620 and thecoupling 640 can be one integral piece. As would be understood by one ofordinary skill in the art, the barrel 620 is adapted to receive asyringe plunger that is axially advanceable and retractable within thebarrel to fill and dispense fluid into and from the syringe in typicalfashion. In some example embodiments, the syringe can be provided foruse with a syringe pump, for example, where one or more portions of thesyringe and/or the plunger can be interengageable with one or moreportions of the syringe pump for moving the plunger relative to thesyringe to dispense fluids from the syringe.

In the depicted example embodiment, the coupling 640 generally comprisesa modified ISO 80369-3 formatted coupling and is engageable with acompatible coupling element such as a corresponding male ISO 80369-3formatted coupling M, as shown in FIG. 4. In example applications, themale ISO 80369-3 formatted coupling M can be part of a feeding orextension tube, a pharmacy cap, syringe (as will be described below) orother enteral fluid delivery equipment to which the syringe 600 is to becoupled.

In example embodiments, a front end 612 of the coupling 640 comprises acylindrical outer collar 642 defining a hollow internal chamber 643, anda pair of helical coupling lugs 644 projecting outwardly from theexterior surface of the collar 642. Optionally, rather than lugs 644projecting from the exterior surface of the collar, the exterior surfaceof the collar 642 can comprise helical threads generally extending aboutat least a portion of the exterior surface thereof, for example, likethreads on a bolt, other types of conventional coupling members, etc. Insome example embodiments, the exterior surface of the collar is entirelysmooth without any lugs, for example, whereby a frictional fit (asdescribed above) will be provided between the male ISO 80369-3 formattedcoupling and the coupling 640. Optionally, other coupling elements canbe provided on the collar as desired.

In example embodiments, the coupling 640 further comprises a lumenextension tip 646 that projects axially from a base portion of thecoupling 640 and into the internal chamber of the collar 642. Accordingto example embodiments, the lumen extension tip 646 is substantiallycoaxial and concentric with respect to the collar 642.

In example embodiments, a second end 614 of the coupling 640 comprisesan end coupling 631 for engagement with an open end 621 of the barrel620. For example, according to one example embodiment, the second end614 comprises an end coupling 631 for sealingly engaging the open end621 of the syringe barrel 620. In example embodiments, the end coupling631 comprises a skirt or outer collar 632 defining a recess or cavity634 and floor surface 635 therein for receiving the open end 621 of thebarrel 620. In example embodiments, the collar 632 comprises an innersurface 633 that is configured for engagement with an outer surface 622of the barrel 620, and an end surface 623 of the syringe abuts with thefloor surface 635 of the cavity 634. Thus, according to some exampleembodiments, both the outer surface 622 and end surface 623 generallysealingly engage or at least abut with the respective inner surface 633and floor surface 635 of the collar 632. According to one exampleembodiment, the outer collar member 642 and the collar 632 have asubstantially similar outer diameter, for example, such that thetransition therebetween (along the length of the coupling 640 from thefirst end 612 to second end 614) is substantially unnoticeable or atleast substantially smooth between the ends. In example embodiments, thecollar 632 of the end coupling 631 is substantially similar to an outerdimension of the female ISO 80369-3 formatted coupling.

An internal lumen or enteral fluid delivery conduit 648 extends throughthe lumen extension tip 646 for fluid communication to and from thecontained volume of the barrel 620, allowing fluid delivery in and outof the barrel 620. As similarly shown and described above, when thecoupling 640 is engaged with a male ISO 80369-3 formatted coupling M,the lumen extension tip 646 is received within the lumen of a malecoupling hub H (in effect becoming a male coupling element within the“female” lumen of the male ISO 80369-3 formatted coupling). The lumenextension tip 646 is generally cylindrical or tubular and includes aninternal surface defining the lumen or fluid delivery conduit 648, acylindrical or slightly tapered external surface, and a distal tip atits free end. The outer coupling collar 642 is also generallycylindrical or tubular, and at least partially surrounding the lumenextension tip 646. The collar 642 comprises an internal surfaceconfronting and spaced a distance apart from the external surface of thelumen extension tip, and further comprises an external surfaceoptionally comprising the lugs 644 or other coupling or connectionfeatures, and an outer rim at its distal free end. The internaldimension of the collar 642 is greater than the external dimension ofthe lumen extension tip 646, such that a space therebetween forms areceiver 643 for a cooperating portion of a compatible coupling element,for example a male ISO 80369-3 formatted coupling. The lumen extensiontip 646 is positioned generally concentrically and coaxially within thecollar 642, and the lumen 648 extends generally centrally through thelumen extension tip also concentric and coaxial with the collar.

In example embodiments, the dosing control coupling 640 is generally aseparate piece, and during the manufacture thereof the dosing controlcoupling 640 is generally sealingly engaged with the syringe barrel 620to form the syringe 600. According to one example embodiment, the dosingcontrol coupling 640 can be permanently and sealingly attached to thebarrel 620, for example by co-molding, over-molding, welding or fusing,adhesives, glues, or other available attachment means. Optionally, thedosing control coupling 640 and syringe barrel 620 can comprise one ormore interengagement features or other coupling elements such that thedosing control coupling 640 can be either permanently or removablyattached to the barrel 620.

In alternate example embodiments, the lumen extension tip 646 can be aseparate piece and installable with the dosing control coupling 640.Thus, according to some example embodiments, the lumen extension tip646, the dosing control coupling 640 and the barrel 640 are separatepieces of the syringe 600. According to another example embodiment asdepicted in FIGS. 28A-B, the barrel 620 and the dosing control coupling640 are separate pieces, and the lumen extension tip 646 is integralwith the dosing control coupling 640. And as shown in FIG. 5 the dosingcontrol coupling, lumen extension tip and barrel are one integralsyringe. Thus, according to example embodiments of the presentinvention, the lumen extension tip can be integrally formed with theintegral coupling or the separate coupling, and further optional thelumen extension tip can be a separate piece for use with the dosingcontrol coupling when the dosing control coupling is integral with thesyringe or when the dosing control coupling is a separate piece.

FIGS. 29A-C show an enteral syringe 700 comprising an enteral dosingcontrol coupling or low-dose tip 746 according to an example embodimentof the invention. In example embodiments, the enteral syringe 700 issubstantially similar to the syringe 10 as described above (see FIG. 5).In some example embodiments, the syringe 700 can be configuredsubstantially similar to the enteral syringe 600, for example, whereinthe dosing control coupling is a separate piece and attached to the openend of the syringe.

In example embodiments, the syringe 700 comprises hollow cylindricalbarrel 720, a base flange 730 at a distal end of the barrel, and theenteral dosing control coupling 740 at a proximal end of the barrel. Inexample embodiments, the enteral dosing control coupling 740 comprises acylindrical outer collar 742 defining a hollow internal chamber 743, anda pair of helical coupling lugs 744 projecting outwardly from theexterior surface of the collar 742. Optionally, rather than lugs 744projecting from the exterior surface of the collar, the exterior surfaceof the collar 742 can comprise helical threads generally extending aboutat least a portion of the exterior surface thereof, for example, likethreads on a bolt, other types of conventional coupling members, etc. Insome example embodiments, the exterior surface of the collar is entirelysmooth without any lugs, for example, whereby a frictional fit (asdescribed above) will be provided between the male ISO 80369-3 formattedcoupling and the coupling 740. Optionally, other coupling elements canbe provided on the collar as desired.

In example embodiments, the coupling 740 further comprises a lumenextension tip 746 that projects axially from a base portion of thecoupling 740 and into the internal chamber of the collar 742. Accordingto example embodiments, the lumen extension tip 746 is substantiallycoaxial and concentric with respect to the collar 742.

An internal lumen or enteral fluid delivery conduit 748 extends throughthe lumen extension tip 746 for fluid communication to and from thecontained volume of the barrel 720, allowing fluid delivery in and outof the barrel 720. As similarly shown and described above, when thecoupling 740 is engaged with a male ISO 80369-3 formatted coupling, thelumen extension tip 746 is received within the lumen of a male couplinghub (in effect becoming a male coupling element within the “female”lumen of the male ISO 80369-3 formatted coupling). The lumen extensiontip 746 is generally cylindrical or tubular and includes an internalsurface defining the lumen or fluid delivery conduit 748, a cylindricalor slightly tapered external surface, and a distal tip at its free end.The outer coupling collar 742 is also generally cylindrical or tubular,and at least partially surrounding the lumen extension tip 746. Thecollar 742 comprises an internal surface confronting and spaced adistance apart from the external surface of the lumen extension tip, andfurther comprises an external surface optionally comprising the lugs 744or other coupling or connection features, and an outer rim at its distalfree end. The internal dimension of the collar 742 is greater than theexternal dimension of the lumen extension tip 746, such that a spacetherebetween forms a receiver 743 for a cooperating portion of acompatible coupling element, for example a male ISO 80369-3 formattedcoupling. The lumen extension tip 746 is positioned generallyconcentrically and coaxially within the collar 742, and the lumen 748extends generally centrally through the lumen extension tip alsoconcentric and coaxial with the collar.

In example embodiments, the enteral syringe 700 can further comprise aflange 722 optionally extending transversely outward from the outercollar 742 (or base portion thereof). In example embodiments, ratherthan the flange 722 only extending along a portion of the outerperiphery of the syringe barrel (see FIG. 2), the flange 722 generallyextends around the entirety of the outer periphery of the outer collar(or base portion thereof). For example, according to example embodimentsof the present invention, the syringe 700 is configured such that thedosing control coupling 740 is a separate piece and assembled forpermanent and sealed engagement with the barrel 720. According to oneexample embodiment, a spacer 721 is provided below the flange 722, andwherein the spacer 721 extends and transitions into a base flange 723that generally tapers outwardly to the dimension of the syringe barrel720. In example embodiments, a seal 724 is provided to sealingly andpermanently attach the base flange 723 (and enteral dosing controlcoupling 740) to the syringe barrel 720 (e.g., by co-molding,over-molding, welding or fusing, adhesives, glues, or other availableattachment means). In alternate example embodiments as similarlydescribed with respect to the enteral syringe 600, the enteral dosingcontrol coupling 740 and be configured for removable engagement with thesyringe barrel 720. Optionally, according to additional exampleembodiments, the dosing control coupling and/or lumen extension tip (asdescribed with respect to syringes 600, 700) can be attached or securedto a syringe barrel as desired, for example, by attachment to thebarrel, the barrel tip, a protrusion or other feature of the barrel, orother barrel fittings, couplings, spacers, flanges, or other aspects andfeatures of any available syringe barrel. In some example embodiments assimilarly described above, the syringe can be provided for use with asyringe pump, for example, where one or more portions of the syringeand/or the plunger can be interengageable with one or more portions ofthe syringe pump for moving the plunger relative to the syringe todispense fluids from the syringe.

FIGS. 30-35 show a plurality of syringes comprising various couplingsaccording to example embodiments of the present invention. In exampleembodiments, the coupling 814 of the syringe 800 of FIG. 30 generallycomprises a modified female ENFit coupling substantially conforming toISO design standard 80369-3, and is engageable with a compatiblecoupling element such as a corresponding male ISO 80369-3 formattedcoupling M, as shown in FIG. 1. In example embodiments, the collar 816of the modified female ENFit coupling does not comprise ribs forengagement with the threaded collar portion of the male ISO 80369-3formatted coupling, but instead comprises a smooth outer surface andsmooth transition to the outer surface of the syringe body. Furthermore,the modified female ENFit coupling comprises a lumen extension tip 817as described above. In some example forms, as depicted in FIG. 31, thecoupling 914 of the syringe 900 comprises only a lumen extension tip 916defining a lumen 918 extending therethrough, for example, for compatibleengagement within the internal conduit of the male ISO 80369-3 formattedcoupling M. According to one example embodiment, the lumen extension tip916 extends a length L5 of between about 5.5 millimeters to about 9.5millimeters. In some example embodiments, as depicted in FIG. 32, thecoupling 1014 of the syringe 1000 extends along the elongate axis X alength L6 of between about 5 millimeters to about 15 millimeters. Inexample embodiments, the coupling 1014 comprises a stepped profilecomprising a first coupling portion 1020, a second coupling portion1022, and a third coupling portion 1024. In example embodiments, thestepped profile comprises generally smooth and radiused transitionsbetween the coupling portions.

In example embodiments, the first coupling portion 1020 comprises atransfer port substantially sized and shaped similarly lumen extensiontip 916 as described above. The second coupling portion 1022 ispreferably sized and shaped for compatible interengagement withenteral-only (EO) formatted couplings, and the third coupling portion1024 is preferably sized and shaped for compatible interengagement withISO 80369-3 formatted couplings (e.g., dimensionally generally similarto ISO 80369-3 formatted male transfer port). Thereafter the thirdcoupling portion 1024, an outer periphery portion of the coupling 1014generally tapers outwardly to the syringe body 1010. Thus, according toexample embodiments, the coupling 1016 preferably comprises a pluralityof coupling portions for providing compatible coupling engagement with aplurality of enteral couplings or formats (e.g., enteral-only (EO) orISO 80369-3 format). Optionally, a plunger can be sized and shaped suchthat the lumen 1018 is entirely occupied with the plunger when fullyinserted within the barrel 1010. U.S. patent application Ser. No.15/652,742 (Attorney Docket No. 2N11.1-422) is incorporated herein byreference and shows a syringe-type delivery device comprising aplurality of coupling portions and a plunger for compatible usetherewith.

As recited above, in example embodiments the delivery of fluid travelsin a direction such that fluid moves from a female ISO 80369-3 formattedcoupling to a male ISO 80369-3 formatted coupling, for example as shownin the embodiments of FIGS. 1-27 (e.g., fluid traveling from a syringe(female ISO 80369-3 formatted coupling) to a coupling (male ISO 80369-3formatted coupling) for delivery to the patient). However, according toadditional example embodiments of the present invention, fluid deliveryfrom the syringe to a coupling or fluid delivery conduit is configuredsuch that fluid moves from a male ISO 80369-3 formatted coupling to afemale ISO 80369-3 formatted coupling. For example, according toadditional example embodiments of the present invention, the endcoupling of the syringe is a male ISO 80369-3 formatted coupling, andthe connector, coupler, other couplings, etc. can comprise female ISO80369-3 formatted couplings (as will be described below).

FIGS. 31-59C show a plurality of enteral syringes and connectorsincluding fluid transfer connectors (e.g., syringe-to-syringeconnectors, transfer caps), and capping or closure components (e.g., tipcaps, fluid transfer connectors, etc.) according to additional exampleembodiments of the present invention. For example, as depicted in FIGS.33-36, the syringes 1100, 1200 comprise a modified male ENFit couplingsubstantially conforming to ISO design standard 80369-3, for example,rather than having a modified female ENFit coupling substantiallyconforming to ISO design standard 80369-3 (as shown in FIGS. 1-27).

In example embodiments, the syringe 1100 can comprise a male ISO 80369-3coupling 1114, for example, which can comprise an outer collar portion1120 with an internally threaded portion 1122 and a centrally-positionedmale coupling hub 1116 extending along an elongate axis X, and a lumen1118 defined within the male coupling hub 1116. Optionally, a protrusionor tab 1130 can extend from a portion of the coupling 1114 (see FIGS.33-34). According to another example embodiment, the coupling of thesyringe 1200 only comprises a male coupling hub 1216 and defines a lumen1218 extending through the hub 1216.

According to example embodiments of the present invention, the male ISO80369-3 formatted couplings 1216 of the syringes 1200 are substantiallysimilar to the male coupling M (e.g., see FIGS. 3A-B and 4 showing amale coupling M and example dimensions thereof). In some exampleembodiments, the coaxial connection collar 1120 of FIGS. 33-34 can bereplaced with one or more clips or generally flexible tabs or otherengagement features for removable engagement with the female ISO 80369-3formatted couplings. According to example embodiments, the one or moreclips can provide for dual-function engagement with the female ISO80369-3 formatted coupling. For example, the dual-function engagementcan provide for rotationally engaging the male and female couplingtogether or for directly pressing one of the couplings relative to theother of the couplings, for example a “press-in” engagement such thatthe one or more clips resiliently flex to provide for passage of the oneor more protrusions or ribs formed on the outside surface of the collarof the female coupling. Optionally, the one or more clips can providefor removable or permanent engagement with a female ISO 80369-3formatted coupling. U.S. patent application Ser. No. 15/454,761(Attorney Docket No. 2N11.1-410), U.S. patent application Ser. No.15/078,674 (Attorney Docket No. 2N11.1-322), U.S. patent applicationSer. No. 15/185,583 (Attorney Docket No. 2N11.1-351), U.S. patentapplication Ser. No. 14/844,922 (Attorney Docket No. 2N11.1-313), U.S.Design Patent Application Ser. No. 29/521,665 (Attorney Docket No.2N11.1-300), and U.S. Design Patent Application Ser. No. 29/533,173(Attorney Docket No. 2N11.1-301) are incorporated herein by referenceand disclose various clipped, snap-on and dual-action attachment andremoval mechanisms for replacement with the coaxial connection collars1120 of the male ISO 80369-3 coupling for the syringes of FIGS. 33-34.Optionally, one or more of the ends of the couplings can be providedwith tabs or clips for providing permanent engagement between thecoupling and the compatible connector, for example, when it is intendedto prevent removal of the coupling 40 (and syringe 10 thereof) from thecompatible connector after use. Further optional, according to someexample embodiments of the present invention, the coupling can compriseone or more channels or grooves, for example, that are generally formedon an outer portion of the coaxial connection collar, for providing forengagement with one or more teeth, ribs, fingers, or engagement membersor tabs, for example, to provide for additional engagement between theconnection of the male and female ISO 80369-3 formatted couplings. Thus,according to some example embodiments of the present invention, theouter coaxial connection collar can be utilized as a bayonet fitting forfurther engagement with one or more portions of the female ISO 80369-3formatted coupling.

According to some example embodiments, the syringes of FIGS. 30-35 canpreferably be utilized as syringe-type fluid delivery devices for orallyadministering fluids, food, medicine or other contents within thesyringe barrel to the mouth of a human or animal patient. U.S. patentapplication Ser. No. 15/652,742 (Attorney Docket No. 2N11.1-422)discloses various syringe-type delivery devices and are incorporatedherein by reference in their entirety.

FIGS. 37A-45D show a plurality of male-to-male, syringe-to-syringe andISO 80369-3 formatted couplings according to additional exampleembodiments of the present invention. For example, when it is desired toconnect or transfer fluids from one syringe to another syringe (forexample, the syringes of FIGS. 33-36), or when it is desired to coupletogether two male ISO 80369-3 formatted connectors, thesyringe-to-syringe couplers as depicted herein can provide for theremovable or permanent coupling engagement of two male ISO 80369-3formatted connectors.

According to some example embodiments as shown in FIGS. 37A-41D, thesyringe-to-syringe couplers 1300, 1400, 1500, 1600 and 1700 eachcomprise a connector member having a generally elongate body extendingalong a longitudinal axis X. In example embodiments, a first end of theconnector member comprises a female ISO 80369-3 formatted coupling andthe second end of the connector comprises a female ISO 80369-3 formattedcoupling. Optionally, according to other example embodiments (as will bedescribed in detail below), one of the ends of the couplers can beconfigured for engagement with syringes or other coupling featuresformatted differently and/or not formatted with ISO 80369-3 format.Preferably, the couplers can be sized and shaped as desired, forexample, for facilitating gripping the coupler, for example at the timeof installation or removal. In some example embodiments, one or both ofthe ends can be fully threaded, can comprise outer ribs or lugs, or canbe substantially smooth for fictional engagement with a male ISO 80369-3formatted coupling. In some example embodiments, one or both of thefemale ISO 80369-3 formatted ends of the couplings can comprise a lumenextension tip, for example, as depicted above with respect to FIGS.1-32. In some example embodiments, where only one side of the ends ofthe coupling comprises a lumen extension tip, the lumen extension tipcan be movable relative to the coupling for example, to generally causeretraction within the end thereof when a misconnection is attempted.

FIGS. 37A-D show a male-to-male coupler 1300 according to one exampleembodiment of the present invention. In example embodiments, the coupler1300 comprises a coupling member 1302 comprising an elongate body 1304extending along the longitudinal axis X from a first end 1310 to asecond end 1320 and defining a lumen 1340 extending therethrough. Inexample embodiments, the elongate body 1304 comprises a length L7 ofbetween about 14 millimeters to about 30 millimeters, for examplebetween about 16 millimeters to about 19 millimeters according to oneexample embodiment of the present invention. In example embodiments, thefirst end 1310 comprises a female ISO 80369-3 formatted coupling and thesecond end 1320 comprises a female ISO 80369-3 formatted coupling. Asdescribed in detail below, the first and second ends 1310, 1320 comprisecylindrical outer collars 1314, 1324 defining hollow internal chambers1312, 1322 that are sized and shaped to receive male ISO 80369-3formatted couplings. Thus, in example embodiments, the couplings asdescribed herein can be configured for sealingly coupling or engagingtogether two male ISO 80369-3 formatted couplings, for example, suchthat fluids from one of the male ISO 80369-3 formatted couplings can betransferred (via the coupling 1300) to the other male ISO 80369-3formatted coupling.

In example embodiments, the coupling 1300 can serve to connect twosyringes together, for example, two syringes wherein each comprises amale ISO 80369-3 formatted coupling, or can serve for connecting themale ISO 80369-3 formatted coupling of a syringe (see FIGS. 33-35) to anISO 80369-3 formatted coupling or system, for example, having aformatted fluid flow configuration (e.g., fluids flowing from female ISO80369-3 coupling to male ISO 80369-3 coupling). For example, accordingto some example embodiments of the present invention, the coupling 1300can comprise a first end comprising a female formatted coupling forconnecting with a syringe comprising a male formatted coupling, and asecond end thereof can comprise a female ISO 80369-3 formatted coupling.Thus, according to certain example embodiments of the present invention,the coupling can preferably comprise an end having a female ISO 80369-3formatted coupling, and another end comprising a format other than theISO 80369-3 format for compatible engagement with other couplingformats. For example, according to example embodiments of the presentinvention, the couplers 1300-2100 can be configured to be adapters, forexample, such that enteral syringes and other enteral feedingcomponents, etc. can be adapted to the ISO80369-3.

Referring back to FIGS. 37A-D, according to example embodiments assimilarly described above (see FIG. 5), each end 1310, 1320 comprises afirst internal diameter D6, a second internal diameter D7, a thirdinternal diameter D9, a length L3, an outer coupler diameter D10, andangle β. According to one example embodiment, the first internaldiameter D6 is about 5.69 millimeters, the second internal diameter D7is about 5.26 millimeters, the third internal diameter D9 is about 2.85millimeters, the length L3 is about 7.14 millimeters, the outer couplerdiameter D10 is about 8.10 millimeters, and the angle β is about 45degrees. Optionally, according to additional example embodiments of thepresent invention, the ends 1310, 1320 of the coupler 1300 can be sizedand shaped as desired.

FIG. 37B shows the coupler 1300 comprising a lumen extension tipintegrally connected with the female ISO 80369-3 formatted coupling ofthe second end 1320. As similarly described above and according to oneexample embodiment of the present invention, the lumen extension tip1346 comprises an outer diameter D16 and an internal diameter D15defining the lumen 1340 extending therethrough. The lumen extension tipextends along the elongate axis X and is coaxially aligned andconcentric with the collar 1324. Optionally, as depicted in FIG. 37C andfurther described and detailed above, the lumen extension tip 1356 ofthe second end 1320 can be movable relative to the coupling 1300 andallow for the retraction thereof towards the first end 1310 when amisconnection is attempted (see FIGS. 12-23). FIG. 37D shows a coupling1300 comprising a lumen extension tip 1346 at each end 1310, 1320thereof. A lumen 1340 extends entirely between the ends 1310, 1320 toallow for fluid communication therethrough, for example, such thatdosing control inaccuracies are substantially eliminated to provide foraccurate dosing control.

FIGS. 38A-D show a coupler 1400 that is substantially similar to thecoupling 1300. In example embodiments, the outer collar 1424 of thesecond end comprises one or more protrusions or ribs 1426 formed on theoutside surface thereof. Optionally, both the first and second ends1410, 1420 can comprise ribs 1424. For example, FIGS. 39A-D shows acoupler 1500 substantially similar to the couplings 1300, 1400, andcomprising one or more protrusions or ribs 1526 formed on outsidesurfaces of each collar 1514, 1524 of both the first and second ends1510, 1520. In example embodiments, the couplers 1500 are configuredsuch that the first and second ends 1610, 1620 comprise female ISO80369-3 formatted couplings. In alternate example embodiments, thesecond end 1520 of the coupling comprises a female ISO 80369-3 formattedcoupling (optionally comprising permanent or removable lumen extensiontip 1546, 1556), and the first end 1510 comprises a coupling formatother than the ENFit ISO 80369-3 coupling format. For example, accordingto example embodiments, the first end 1510 of the coupling 1500comprises a coupling format other than ISO 80369-3, and wherein syringeor delivery device comprising the coupling format other than ISO 80369-3can sealingly connect with the first end 1510 of the coupling 1500, andthereby providing an adaptor such that coupling formats other than ISO80369-3, for example, syringes and delivery devices (with other threadedenteral coupling formats), are connectable with ISO 80369-3 formattedcouplings. According to further example embodiments, the lumen extensiontip 1546, 1556 provides reduction to the volume of the conduit 1540, forexample, such that dosing control inaccuracies are substantiallyeliminated to provide for accurate dosing control.

According to one example embodiment and shown in FIGS. 40A-D, ratherthan the second end 1420 of the coupling 1400 comprising one or moreprotrusions 1426 (see FIGS. 38A-D), the coupling 1600 comprises a secondend 1620 having helical threads 1626 generally extending about at leasta portion of the outer surface thereof, for example, like threads on abolt, other types of conventional coupling members, etc. Similar to thecoupling 1400, the outer collar 1614 of the first end 1610 comprises asubstantially smooth outer surface configured for frictional and sealingengagement with a male formatted coupling, for example which can be inthe form of an ISO 80369-3 formatted coupling, or for example, can beformatted according to other coupling formats (e.g., EO, lure, lurelock, other available coupling formats, etc.). Optionally, as depictedin FIGS. 41A-D, both ends 1710, 1720 can comprise helical threads 1726formed on the outer collars 1714, 1724 thereof.

Optionally, according to another example embodiment of the presentinvention, the couplings as shown in FIGS. 37A-41D can further compriseone or more additional features to improve grasping or gripping thecoupler during use. For example, according to one example embodiment asshown throughout FIGS. 42A-45D, the couplings 1800, 1900, 2000 and 2100comprise one or more protrusions or helical coupling lugs 1826, 1926,2026, 2126 projecting outwardly from the exterior surface of the collarsat the first and second ends thereof. Optionally, rather than lugsprojecting from the exterior surface of the collar, the exterior surfaceof the collar can comprise helical threads generally extending about atleast a portion of the exterior surface thereof, for example, likethreads on a bolt, other types of conventional coupling members, etc. Insome example embodiments, the exterior surface of the collar is entirelysmooth without any lugs, for example, whereby a frictional fit (asdescribed above) will be provided between the male ISO 80369-3 formattedcoupling and one of the ends of the coupling. Optionally, other couplingformats can be provided on one of the ends, for example as describedabove. Optionally, a lumen extension tip 1846, 1946, 2046, 2146 can beprovided with one or both ends of the couplings and define a respectivelumen 1840, 1940, 2040, 2140 extending therethrough. FIGS. 42A-C show acoupler 1800 comprising an outer barrel 1860 comprising one or more ribsor connecting members 1864 for generally coaxially and concentricallyaligning the outer barrel 1860 with the coupling member 1802. Accordingto example embodiments, one or more vents 1866 can be provided, forexample wherein one or more of the connecting members 1864 are generallyspaced apart about a circular array. According to other exampleembodiments, the connecting member 1864 can be substantially solid andcomprise one or more holes or other openings extending entirelytherethrough. According to additional example embodiments, the couplingcan be configured as desired, for example, to further assist in graspingor gripping the coupler during use. According to one example embodiment,the outer barrel 1860 can be replaced with one or more gripping panels1960 defining outer surfaces 1962 (see FIGS. 43A-D). In exampleembodiments, a connecting member or transverse flange 1964 generallyconnecting the one or more gripping panels 1960 to the coupling member1902. U.S. patent application Ser. No. 15/185,583 (Attorney Docket No.2N11.1-351) discloses syringe-to-syringe couplers comprising one or moregripping panels or an outer barrel, the entirety of which isincorporated herein by reference. Optionally, one or more vents canextend through the entirety of the flange 1964.

According to another example embodiment and depicted in FIGS. 44A-D, thecoupler 2000 comprises a centrally-positioned collar member ordisc-shaped protrusion 2060 that extends outwardly around the entireouter periphery of the coupling member 2002 (generally about at themidpoint of the body 2004). In example embodiments, an outer surfaceprofile 2062 can be provided, for example such as the depictedundulating pattern comprising a plurality of alternating peaks andvalleys along the outer periphery of the circular profile. According toone example embodiment, the protrusion 2060 provides the user oroperator a coupling which can easily be grasped by one or more fingersof the user or operator, and can be easily manipulated (e.g., rotationfor attachment/detachment).

FIGS. 45A-D show a coupler 2100 comprising a tab 2160 extending from aportion of the coupling member 2102. In example embodiments, the tab2160 is generally comprises an oval or circular outer profile 2162 orfor example comprising a tear-drop shape, for example with a generallyoval-shaped outer profile 2162 having one end thereof connected to thecoupling member 2102. In example embodiments, the tab 2160 can compriseone or more ribs, protrusions, or other surface features 2164. Accordingto one example embodiment, the tab 2160 can comprise an opening 2166 tofunction as a gripping feature, or for example, an eyelet or forengagement with a tether or other engagement feature, or for example twoend caps for removable engagement with the first and second ends of thecoupling 2100 (the end caps being connected to the opening 2166 by atether). Optionally, the tab 2160 and/or gripping feature thereof can beshaped and sized as desired.

In alternate example embodiments, for example when the delivery of fluidtravels in a direction such that fluid moves from a female ISO 80369-3formatted coupling to a male ISO 80369-3 formatted coupling, an adaptorcan be provided such that a syringe comprising a female ISO 80369-3formatted coupling without the lumen extension tip extending therein ismodified to have a female ISO 80369-3 formatted coupling with the lumenextension tip extending therein. For example, a first end of the adaptorcan comprise a male ISO 80369-3 formatted coupling (e.g., for connectingto the female ISO 80369-3 formatted coupling) and a second end of theadaptor can comprise a modified female ISO 80369-3 formatted couplingcomprising a lumen extension tip, for example, as described herein.Thus, for syringes comprising the female ISO 80369-3 formatted couplingand not comprising a lumen extension tip extending axially therein, theadaptor as described above can be connected to the syringe such thatdosing inconsistencies and anomalies in accuracy during fluid deliveryare further reduced, minimized or substantially eliminated.

FIGS. 46A-47B show a fluid transfer lid 2200 according to anotherexample embodiment of the present invention. In example embodiments, thetransfer lid 2200 as depicted herein preferably provides for couplingengagement with a pharmacy bottle or other container comprising a liquidmedicine or fluid, for example, which is to be transferred (by small orlarge doses) to a syringe. Thus, in example embodiments where thecoupling of the syringe is in the form of a male ISO 80369-3 formattedcoupling, the transfer lid 2200 for compatible engagement therewithcomprises a female ISO 80369-3 formatted coupling, for example, whichcan comprise one or more outer ribs (see FIG. 46A), threads (see FIG.46C), or can be substantially smooth (see FIG. 46B). As depicted inFIGS. 47A-B, a lumen extension tip 2227, 2228 can be incorporated withthe female ISO 80369-3 formatted coupling. In some example embodiments,the lumen extension tip is substantially integral with the female ISO80369-3 formatted coupling (see FIG. 47A). As depicted in FIG. 47B, aflexible membrane 2229 is attached to a separate dosing control coupling2228, which is positioned to be biased within the internal conduit 2224of the female coupling 2220, and wherein the membrane 2229 is generallysealed with an inner surface of the cap, and wherein the dosing controlcoupling 2228 remains biased to fully extend within the internal conduitof the coupling. In example embodiments, when a misconnection isattempted with the dosing control coupling, the dosing control couplingretracts as depicted in FIG. 47B, for example, such that themisconnection cannot be achieved. U.S. patent application Ser. No.14/960,905 (Attorney Docket No. 2N11.1-241) is incorporated herein byreference and shows transfer lids for use with enteral connectors.Optionally, the fluid transfer lid can be configured for venting, forexample, to relieve any vacuum created during the transfer of fluidsfrom the bottle attached with the fluid transfer lid. U.S. patentapplication Ser. No. 14/844,910 (Attorney Docket No. 2N11.1-211) isincorporated herein by reference and discloses a transfer lid having avented slot.

FIGS. 48-55 show a plurality of tip caps according to additional exampleembodiments of the present invention. As depicted and according to theembodiments of FIGS. 48-54, a tip cap 2300 extends from a first end 2312to a second end 2314, and the second end 2314 comprises a female ISO80369-3 formatted coupling for engagement with a male ISO 80369-3formatted coupling, for example, with the male ISO 80369-3 formattedcoupling of the syringes of FIGS. 33-35. Preferably, the tip cap canoptionally comprise a dosing control coupling 2330, 2332, for example,which can be substantially solid or comprise a hollow reservoir therein,for example, for generally extending within the internal conduit of themale ISO 80369-3 formatted coupling, for example, to act as a plug,stopper or medium for preventing fluids within the syringe from furtheroccupying the internal conduit of the male ISO 80369-3 formattedcoupling. In some example embodiments, the tip caps as described hereinare preferably self-righting, for example, such that the orientation ofthe tip cap in a rest position is generally configured such that thefemale ISO 80369-3 formatted coupling is generally facing upwards. Insome example embodiments, the tip cap can comprise one or more vents,for example, as described in U.S. patent application Ser. No.14/844,922, the entirety of which is incorporated herein by reference.In some example embodiments, the tip can comprise a substantially largebase, for example, which can prevent the tip cap from being a chokinghazard, and which can function as a stand to orient the syringe in avertical manner when coupled thereto.

Optionally, as depicted in FIG. 55, the female connector of the secondend 2414 is configured for engagement with a coupling format other thanthe ISO 80369-3 format. According to one example embodiment of thepresent invention, the female connector is configured for compatiblecoupling engagement with an end portion of an applicator or tube, forexample, for capping an end portion of an applicator tube 2540 of anoral administration coupler 2500 (see FIGS. 56A-59D). Optionally, alumen extension tip or other male projection 2422 can be provided forfitting within a lumen of the tube 2540 when the cap 2400 is engagedtherewith.

In example embodiments, the oral administration coupler 2500 comprisesan end for coupling to a syringe, for example, a female ISO 80369-3formatted coupling, and another generally opposite end for deliveringfluids orally to a patient, for example, within the patient's mouth. Insome example embodiments, the female ISO 80369-3 formatted coupling cancomprise a dosing control coupling, or for example, can be formed fromtwo or more separate materials and comprise one or more flexibleportions such that fluids can be delivered to the back of the patient'smouth. U.S. patent application Ser. No. 15/078,674 (Attorney Docket No.2N11.1-322) and U.S. patent application Ser. No. 15/652,742 (AttorneyDocket No. 2N11.1-422) disclose various oral administration couplers andare incorporated herein by reference in their entirety.

For example, FIGS. 56A-57D show a plurality of oral administrationcouplers 2500 configured for back-of-mouth delivery, which generallycomprise a coupling member 2520 and a generally elongate straw ordelivery tube 2540 extending from the coupling member 2520. In exampleembodiments, an end of the coupling member comprises a female ISO80369-3 formatted coupling, for example, which can comprise one or moreribs 2524 (see FIGS. 56A, 56C, 57A, 57C) or can be fully threaded (seeFIGS. 56B, 57B). Optionally, as depicted in FIGS. 56C and 57C, thefemale ISO 80369-3 formatted coupling can comprise a dosing controlcoupling 2521 as described above. In example embodiments, the oraldelivery applicator 2540 comprises a generally elongate tube extending alength sufficient for delivering medications orally.

FIGS. 58A-59B show an oral administration coupler 2600 according toanother example embodiment of the present invention. According to thedepicted example embodiment, the oral administration coupler 2600comprises a first end 2612 and a second end 2614, for example, wherein acoupling portion 2620 is provided at the second end 2614 and anapplicator 2630 at the first end 2612. In example embodiments, thecoupling portion 2620 comprises a female ISO 80369-3 formatted couplingand the applicator 2630 is generally elongate for assisting in the oraldelivery of fluids to a patient's mouth. In example embodiments, thecoupling portion 2620 comprises a collar 2622, a hollow internal chamber2617, one or more protrusions 2624 formed on an outside surface of thecollar 2622, and a lumen 2616 extending entirely from the first end 2612to the second end 2614.

According to example embodiments, the coupling portion 2622 canoptionally comprise helical threads 2624 on an outside surface of thecollar 2624 (see FIG. 58B, 59B) as similarly described above, or forexample can comprise a lumen extension tip 2623 axially extending withinthe hollow internal chamber 2617 of the collar 2622. According toexample embodiments, an outer flange 2640 can be formed with the coupler2600 as desired. According to one example embodiment, the flange 2640 isconfigured to mitigate choking risks. U.S. patent application Ser. No.15/652,742 (Attorney Docket No. 2N11.1-422) shows a plurality of oraladministration couplers, the entirety of which is incorporated herein byreference.

While the invention has been described with reference to exampleembodiments, it will be understood by those skilled in the art that avariety of modifications, additions and deletions are within the scopeof the invention, as defined by the following claims.

What is claimed is:
 1. An enteral coupler comprising a coupling membercomprising an elongate body extending a length along a longitudinal axisfrom a first end to a second end and defining a lumen extendingtherethrough, the first end comprising a female formatted coupling andthe second end comprising a female formatted coupling, wherein at leastone of the female formatted couplings comprises a female ISO 80369-3formatted coupling.
 2. The enteral coupler of claim 1, wherein thefemale formatted coupling of the first and second ends each comprise afemale ISO 80369-3 formatted coupling.
 3. The enteral coupler of claim1, wherein the coupler is configured for coupling a first male ISO80369-3 formatted coupling with a second male ISO 80369-3 formattedcoupling.
 4. The enteral coupler of claim 3, wherein a first enteralsyringe comprises the first male ISO 80369-3 formatted coupling and asecond enteral syringe comprises the second male ISO 80369-3 coupling,and wherein the coupler provides for sealingly connecting the first maleISO 80369-3 formatted coupling of the first syringe to the second ISO80369-3 formatted coupling of the second syringe.
 5. The enteral couplerof claim 1, wherein the female formatted coupling of the first endcomprises a female ISO 80369-3 formatted coupling and wherein the femaleformatted coupling of the second end comprises a coupling format otherthan the female ISO 80369-3 format.
 6. The enteral coupler of claim 5,further comprising a syringe comprising a coupling format other than thefemale ISO 80369-3 coupling format, and wherein the syringe isconfigured for sealingly coupling to the second end of the coupler suchthat the enteral coupler adapts the syringe of a coupling format otherthan the female ISO 80369-3 coupling format to the female ISO 80369-3coupling format.
 7. The enteral coupler of claim 1, wherein the lengthof the coupler is between about 14 millimeters to about 30 millimeters.8. The enteral coupler of claim 1, wherein at least one of the collarportions of the female formatted coupling comprises an engagementfeature formed on an exterior surface thereof and selected from thegroup consisting of a protrusion, a lug and a helical thread.
 9. Theenteral coupler of claim 1, further comprising a lumen extension tipprojecting axially into an internal chamber of a collar of at least oneof the female formatted couplings.
 10. The enteral coupler of claim 9,further comprising a lumen extension tip projecting axially intorespective internal chambers of collars of the female formattedcouplings of the first and second ends.
 11. The enteral coupler of claim9, wherein the lumen extension tip is a separate piece and configuredfor coupling engagement with the enteral coupler.
 12. The enteralcoupler of claim 1, further comprising at least one gripping featureselected from one or more panels, an outer barrel, a disc-shapedprotrusion or a tab.
 13. An enteral connector for coupling engagementwith a syringe comprising a male ISO 80369-3 formatted coupling, theconnector comprising a female ISO 80369-3 formatted coupling comprisinga cylindrical outer collar defining a hollow internal chamber and alumen extending entirely through the outer cylindrical collar.
 14. Theenteral connector of claim 13, further comprising a lumen extension tipprojecting axially into an internal chamber of the outer cylindricalcollar.
 15. The enteral connector of claim 13, wherein the enteralconnector comprises an enteral coupling selected from a group consistingof a fluid transfer lid, a tip cap, and an oral administration coupler.16. The enteral connector of claim 13, wherein the outer cylindricalcollar further comprises an engagement feature formed on an exteriorsurface thereof and selected from the group consisting of a protrusion,a lug, and a helical thread.
 17. The enteral connector of claim 14,wherein the lumen extension tip is sized, shaped and positioned withinthe outer cylindrical collar of the female ISO 80369-3 formattedcoupling for compatible fitting engagement within an internal conduit ofthe male ISO 80369-3 formatted coupling.